Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital


  • Giacomo Pietro Vigezzi School of Medicine, Vita-Salute San Raffaele University
  • Alessandra Lume School of Medicine, Vita-Salute San Raffaele University
  • Massimo Minerva School of Medicine, Vita-Salute San Raffaele University
  • Paola Nizzero Infection Control Committee, IRCCS San Raffaele Hospital
  • Anna Biancardi Infection Control Committee, IRCCS San Raffaele Hospital
  • Vincenza Gianfredi School of Medicine, Vita-Salute San Raffaele University
  • Anna Odone Department of Public Health, Experimental and Forensic Medicine, University of Pavia
  • Carlo Signorelli School of Medicine, Vita-Salute San Raffaele University
  • Matteo Moro Infection Control Committee, IRCCS San Raffaele Hospital


vaccination, COVID-19, vaccine, cross-sectional study, pharmacovigilance, adverse drug reaction reporting systems


Background and aim: Comirnaty® was the first COVID-19 vaccine available for the vaccination campaign of healthcare workers in Italy. With the aim of assessing vaccine safety, we conducted a cross-sectional survey administrating a voluntary-based questionnaire on adverse events following immunisation (AEFIs) in San Raffaele Hospital, Milano, Italy.

Methods: From 4th January 2021 to 27th April 2021, we collected 2,659 questionnaires (response rate: 24,5%). We analyzed data, reporting AEFIs by gender, age, self-reported severity, type, time of insurgence and duration, and estimating relative-risk ratios (RRR) and corresponding 95% confidence intervals (CI).

Results: The most reported symptoms were injection site pain, fatigue, headache, myalgia, chills, fever, and arthralgia. Severe systemic reactions were more frequent after receiving the second dose (RRR 6.25, 95% CI 4.57-8.55), in women (RRR 3.33, 95% CI 2.30-4.82), and less frequent in individuals aged 60 or more (RRR 0.26, 95% CI 0.14-0.49). In addition, we noted a wide range of adverse events of special interest (AESIs).

Conclusions: Consistently with clinical trials and pharmacovigilance surveillance, AEFIs were frequent, but severe ones were uncommon, supporting the massive implementation of the COVID-19 vaccination campaign and providing valuable data for a risk profiling of vaccinees. (


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How to Cite

Vigezzi GP, Lume A, Minerva M, Nizzero P, Biancardi A, Gianfredi V, et al. Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital. Acta Biomed [Internet]. 2021 Oct. 1 [cited 2024 Jul. 24];92(S6):e2021450. Available from: